BELTSVILLE, Maryland (Reuters) - An experimental Solvay SA
drug for a potentially fatal heart ailment could lead to deaths
if used broadly in the population, a U.S. medical reviewer will
argue on Wednesday.

The assessment comes as a U.S. Food and Drug Administration
advisory panel mulls whether to recommend approval of the
intravenous drug for atrial fibrillation (AF).

The committee will vote later this afternoon on whether to
advise approval of the drug, known generically as tedisamil.

In AF, the heart's upper chambers do not pump effectively,
putting patients at risk for blood clots and strokes. About 2.2
million Americans suffer from the condition.

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"With widespread use if approved: There will be deaths from
ventricular arrhythmias (abnormal heartbeat rhythm); there will
be deaths from bradycardia (slow heart beat) and hypotension
(low blood pressure)," Thomas Marciniak, FDA's medical team
leader for the cardiovascular and renal unit, said in a
document prepared for the advisory panel meeting.

"What will happen to safety in real-world use, particularly
considering the complex dosing?" he wrote.

A Solvay official presented a plan to control risks of the
drug if it is approved, by monitoring patients and employing a
data safety board to continually assess benefits and risks.

The plan "should effectively mitigate the concerns related
to the use" of the drug by "pro-actively addressing the known
risks," said Earl Sands, the Belgian company's chief medical
officer for U.S. research.